Consent Form for Participation in a Subject Recruitment Database University of Massachusetts Amherst Name of Researcher: Name of Subject Recruitment Database: 1. WHAT IS THIS FORM? This form is called a Consent Form. It will give you information about the Subject Recruitment Database so you can make an informed decision about whether or not you would like your name and information to be included in this catalogue of information. 2. WHAT IS THE PURPOSE OF THIS SUBJECT RECRUITMENT DATABASE? The purpose of this subject recruitment database is … 3. WHO IS BEING ASKED TO PARTICIPATE IN THIS DATABASE? [Describe the characteristics of desired participants including gender, age, health limitations, medical conditions, etc. ] 4. WHAT WILL MY PARTICIPATION IN THIS DATABASE INVOLVE? If you agree to be included in the subject recruitment database …. [Describe what information will be requested, how it will be obtained, how it will be used, how subjects may be contacted in the future for studies, how often subjects will be contacted, and explain that there this is only one of several recruitment databases at UMASS Amherst…] 5. WHAT ARE THE POSSIBLE BENEFITS OF MY PARTICIPATION IN THIS DATABASE? [Use the following suggested statement for this section:] “You may not directly benefit from being included in this database; however, we hope that your inclusion in the database may …(describe societal benefits).” 6. WHAT ARE THE POSSIBLE RISKS OF MY PARTICIPATION IN THE DATABASE? [Inform the participant of any risks associated with being included in the database (mainly confidentiality?)] 7. HOW WILL MY PERSONAL INFORMATION BE PROTECTED? [Describe protections that you will use to keep the electronic or hard copy information secure. How will you provide information to colleagues eligible to use the data?] For example: “The researchers will keep all database records in a secure location. All electronic files (e.g., database, spreadsheet, etc.) containing identifiable information will be password protected. Any computer hosting such files will also have password protection to prevent access by unauthorized users.” Page 1 of 2 Version 1 Initials ___ 8. WHO WILL HAVE ACCESS TO MY INFORMATION? Only the members of the research staff will have access… [If database information is to be released, describe the person(s) to whom information will be furnished, the nature of the information to be furnished, the purpose of the disclosure and whether the participant’s name will be used.] 9. WHAT IF I HAVE QUESTIONS? [Include the following required information on all consent forms]. “Take as long as you like before you make a decision. We will be happy to answer any question you have about this study. If you have further questions about this database you may contact [insert name and phone number of database researcher]. If you have any questions concerning your rights as a research subject, you may contact the University of Massachusetts Amherst Human Research Protection Office (HRPO) at (413) 545-3428 or humansubjects@ora.umass.edu. 10. MAY I WITHDRAW MY CONSENT FOR PARTICIPATION IN THE DATABASE? [Required statement to begin section:] r “You do not have to be a part of this database if you do not want to. If you agree to be in the database, but later change your mind, you may drop out at any time. There are no penalties or consequences of any kind if you decide that you do not want to participate.” 11. SUBJECT STATEMENT OF VOLUNTARY CONSENT [Use the following required statement and format for this section:] “I have read this form and decided that I will participate in the subject recruitment database. The general purposes and particulars of the database as well as possible hazards and inconveniences have been explained to my satisfaction. I understand that I can withdraw at any time.” ________________________ Participant Signature: ____________________ Print Name: __________ Date: By signing below I indicate that the participant has read and, to the best of my knowledge, understands the details contained in this document and has been offered a copy. _________________________ Signature of Person Obtaining Consent ____________________ Print Name: __________ Date: Page 2 of 2 Version 1 Initials ___